Description

Palonosetron Impurity Tm1-Ss is a designated impurity standard used in the analytical profiling and quality control of the antiemetic drug Palonosetron. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs departments for method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Palonosetron HCl active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating stability-indicating chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to confirm the impurity levels are within ICH Q3A/B specified limits for new drug substances and products.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Research & Development: Used in R&D to understand the degradation pathways and synthesis process of Palonosetron.

Basic Information

Product Name	Palonosetron Impurity Tm1-Ss
CAS No.	1260610-96-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palonosetron Related Compound Tm1-Ss; Palonosetron Impurity; (3aS)-2-[(3S)-1-Azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4-tetrahydro-1H-benz[de]isoquinolin-1-one (related to Palonosetron); Palonosetron Process Impurity; Palonosetron Degradant; Anti-emetic Drug Impurity
EINECS	Contact for details

Quality Control

Every batch of Palonosetron Impurity Tm1-Ss is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against stringent in-house specifications. We support compliance with ICH, USP, and EP guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.